Gilead’s Truvada approved for PrEP
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.
The FDA announced the approval of Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) in adults who don’t have HIV but are at high risk of becoming infected, also known as pre-exposure prophylaxis, or PrEP. For the new indication, the drug is designed to be taken once per day and combined with safer sex practices such as "consistent and correct" condom use, risk-reduction counseling, regular HIV testing and treatment of any other sexually transmitted infections; the drug is not meant as a substitute for safer sex practices.
"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world, it still is," FDA Division of Antiviral Products director Debra Birnkrant said. "Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV."
The approval was based on two clinical trials showing that daily use of Truvada reduced the risk of HIV infection by 42% in gay and bisexual men and transgender women and by 75% in HIV-negative people with opposite-sex partners who were HIV-positive.
Sanofi Pasteur begins shipping Fluzone in U.S. for 2012-2013 season
SWIFTWATER, Pa. — Sanofi Pasteur has begun shipping the first lots of its influenza vaccine for the 2012-2013 season.
The announcement follows the Food and Drug Administration licensure of the 2012-2013 formulation, the drug maker said. In addition to the strain change in the 2012-2013 vaccine, Sanofi Pasteur said its syringe presentations of Fluzone (approved for those ages 6 months and older) and Fluzone High-Dose (ages 65 years and older) vaccines have a new syringe cap that does not contain latex. All presentations of Fluzone vaccine have the designation "does not contain latex," which should mitigate concerns about use in patients with a latex allergy.
Sanofi Pasteur also noted that the Fluzone Intradermal vaccine — which was introduced in 2011 with limited availability — will be widely available for the 2012-2013 season. The formulation is recommended for those ages 18 years to 64 to years.
"This year, two new virus strains were recommended for the seasonal influenza vaccine formulation," Sanofi Pasteur VP and chief commercial officer Chad Hoover said. "It is a tremendous logistical challenge for public health to try to immunize everyone 6 months of age and older in the few months prior to influenza season. As the supplier of nearly half of the nation’s influenza vaccine, it was a critical challenge for us to be early to market so that healthcare providers had confidence in their supply of influenza vaccine. With the confidence of early vaccine delivery, healthcare providers can start immunizing sooner and commit to scheduling immunization clinics throughout the season."
Cardinal Health shares indie pharmacy best practices publication at wholesaler’s RBC
ORLANDO, Fla. — Cardinal Health this week introduced "Independent Pharmacy Best Practices 2012, Ideas as Original As You Are," a special publication that showcases 16 unique programs that improve patient care and drive business results, at the wholesaler’s annual Retail Business Conference here.
“We work every day with forward-thinking pharmacists who are constantly finding new ways to build stronger, more resilient businesses and improve the quality of care they deliver to patients,” stated Steve Lawrence, SVP independent sales for Cardinal Health. “We’re thrilled to share some of these best practices at RBC 2012, and we congratulate this year’s honorees and finalists for their commitment to community pharmacy excellence.”
During the RBC 2012’s Customer General Session, event attendees viewed videos highlighting the three finalists, and were invited to ‘text to vote’ for the most innovative best practice. The winner of the text-to-vote competition was Marty Bigner of Thrift Drugs in McComb, Miss. Cardinal Health will donate $10,000 to the organization of Bigner’s choice in his honor.
The three independent pharmacies that were recognized as finalists during Cardinal Health’s Best Practices text-to-vote competition at RBC 2012 include:
- McComb, Miss.-based Thrift Drugs, which implemented a Free Vitamin Club for children. Owner Marty Bigner invites community members to sign up children between the ages of 2 and 12, and promotes the program through local radio and print ads, his storefront signs, flyers and at local health fairs. In the program’s first year, nearly 290 children were enrolled in the program, representing more than 100 families — half of which had not visited Thrift Drugs before. Bigner views the program as a great, low-cost way to develop patient relationships and patient loyalty;
- Hobbs Pharmacy in Merritt Island, Fla., which implemented a synchronized refill program for many of its high-prescription-volume patients, defined as patients who take between 15 and 20 different prescription medications. Pharmacy staff synchronize each patient’s prescriptions and his or her corresponding refill timelines; and then work with prescribing physicians to get all medications on a synchronized refill schedule, so patients only need to visit the pharmacy once or twice per month. This Meds Made Easy program enables Hobbs Pharmacy to better identify adherence issues and to improve its collaboration with doctors; and
- Reddish Pharmacy in Nampa, Idaho, which worked with the leaders of the local school system to begin offering teacher flu clinics at local schools. In just the first month and a half, Reddish had booked 25 flu vaccine clinics at local schools, and in just the first year of the program, increased its vaccine business from 200 to more than 850 immunizations. Reddish also leveraged the Teacher Immunization Program to earn teachers’ prescription business by encouraging teachers to sign up for an auto-refill program and offering to deliver teachers’ prescriptions directly to them at school at no additional cost.